AVITA Medical, Inc. (RCEL) Earnings Call Transcript & Summary

Thank you for joining this AVITA Medical quarterly Australian webinar. Also good afternoon to those of you dialing in from the U.S. I'm Rudi Michelson of Monsoon Communications. AVITA CEO, Jim Corbett, he's back in Australia for his Sydney-Melbourne roadshow this week, with CFO, David O'Toole. And this webinar has been arranged, so everyone has a chance to be brief, direct, and ask questions on AVITA's progress. Now let me point out you can submit questions using the Q&A function and we'll get to them after the presentation. So presenting today is Jim Corbett and assisted by David O'Toole. The webinar is being recorded. I'll now hand over to Jim Corbett to begin the presentation.

Thank you, Rudi, and good morning from Melbourne. One of the things that we've been striving to do for the last 1.5 years is to really spend time with our shareholders, both here in Australia and in the United States. And during this -- this will be my sixth trip in the last 6 quarters, and we intend to keep doing that so that we maintain a good, close relationship and communication with our shareholders. So today, we are reviewing the end of year 2023 results and status on various projects. Let me introduce you here to the management team. We have made a few changes over the last year, but the team that we have today, it is very experienced, very capable, and by the results, doing their job quite well. For those of you who might be listening and learning about AVITA for the first time, we are a commercial-stage company focused on regenerative medicine. And when I say that, what I'm really referring to is wound healing. The RECELL technology is a wound-healing technology. It has some other applications, one of which is called vitiligo, and I'll talk about that separately. But our core business is treating burns as a wound and full-thickness skin defects, which is almost every use you can imagine for a skin graft. Now, we're currently -- last year, we expanded the sales -- commercial team to 70 total professionals and did so before the full thickness skin defect expansion of our indication in June. We actually are expanding again to take up the demand. We continue to grow at a very fast rate and the demands on our team are high. So that expansion is going to fuel our path to profitability, which I'll share with you later in the call. Originally, we were approved to sell in 140 burn centers prior to June of last year. And now as we move forward into full thickness, we expect to add 200 new accounts this new year in 2024. That's out of 750 possible. And to give you some perspective on how much the opportunity for our products has become with this latest indication is that from a patient orientation, there were 35,000 -- there are 35,000 patients who had burn injuries, who are eligible for a graft. However, in full-thickness skin defect, there's 400,000 patients, so more than tenfold. So this is really a big opportunity for the company, and we are essentially without a direct competitor. And if you look at our revenue growth over the last 4 quarters, 40% in Q1, 42% in Q2, 51% in Q3, 50% in Q4. And as you'll later learn, now we have a higher base number, but the midpoint of our guidance is nearly 60% for 2024. We're also taking this wound care issue in terms of the definition of the company very seriously, and we've begun acting on expanding our portfolio. And we'll spend some time talking about the agreement with a specialty dressing called PermeaDerm manufactured by a company called Stedical Scientific. So I'll be sharing that with you as well. So a lot to talk about. This is a review just from which you've seen before, talking about the different indications, their status of approval. And you can see that as of 2024, we actually have all our primary indications approved. And now we're in one stage or another of launching or preparing to launch. Again, a little bit of a review about how RECELL is used, how it's been used historically. What you see on the left is the kit. And what happens is the patient -- the doctor takes a biopsy for the patient. And I want to put that into some perspective for you. When you think skin graft, you have to cover the totality of the wound with graft material. When you're using RECELL, what's happening, if you just -- if you can imagine in your brain the idea that you had a burn on your total back, the amount of skin biopsy you need to take is about the size of a credit card. So that is referred to as tissue sparing. We take that tissue and we disaggregate it in the tray that you can see in the middle here of the slide. We disaggregate those cells, suspend them in an enzyme buffering solution and we spray them on the wound. Now this has a big effect on the healing, both in timing and scarring and time in the hospital. The American Burn Association looked at patients by their total body surface area equivalence and whether they were treated with RECELL or conventionally. And found that when treated with RECELL, they left the hospital 30% sooner than treated with standard means, which is, if you think about that, way better for the patient, better for the hospital, and better for the physician. Everybody really is happy with that outcome. Now we're going to talk about the next-generation RECELL device. On the left, as you can see, is the original device. What you see in the middle is what we call the durable. It's about the size of a blender on the top of your counter. And what you see on the right is a cassette where we put the enzyme, the buffering solution, and the biopsy. And basically, you fill those wells, you put in the skin biopsy material, you push it into the device, it locks and you press one button and in about 25 minutes to 30 minutes, the solution is ready for spray-on application. So from a benefit point of view, what it's doing is just controlling for 2 important variables. One, you can imagine that the disaggregation is done under the hand pressure of hundreds of different surgeons. So it's highly variable. Under the RECELL GO scenario, the pressure to disaggregate the cells is calibrated to maximize the living cells. Too much pressure is bad, too little pressure is bad. Secondarily, it standardizes the soak time in the enzyme. Now the enzyme has some additives to it, which are in a trade secret category. But suffice to say that what they do is they cause that cell suspension and the cells within it to survive and thrive. And they survive by making it a pH where the cells survive longer and thrive as those additives provide metabolic support essentially feeding the cells. So when they are sprayed onto the wound, those cells have a high percentage, who are viable and ready to clean onto the wound and we begin the process of healing. So the RECELL GO device, this is the standard size that you see here on the right, which treats 1,920 square centimeters. And that will be the same size as what the manual device was. So this is the RECELL device going to what we call RECELL GO. And RECELL GO refers to the durable and the cassette, which will replace the device you see on the left. Let's spend a minute talking a little bit about our full-thickness launch. So many things line up here for us. First of all, they use the same DRG codes, so we have reimbursement in the hospital. We have reimbursement through transitional pass-through code. Half of the burn centers that we were already treating in have -- are in level 1 trauma centers. So they actually were able to start using RECELL in other indications immediately last June. As well, the burn world at 35,000, actually, we called on just about 25,000 of those cases in those 140 burn centers because the 10,000 other burns are in level 1 trauma center. So our field expansion now allows us to capture the full burn market. In Q2 last year, we went from 30 to 70. And one of the things we set at the time was when we saw $2 million per head of salesperson, in our future sites, we would expand again. And why is that? And we'll get into it. But the simple thing is when we want -- what we want is deep selling broad indications in a large geographic territory or a large revenue territory slow the growth down in the company. And of course, at 85% gross profit, our growth will get us to our Q3 next year '25 profitability goal. In April 1, we are not going to expand the commercial organization, we will have done it. We started on January 18 and a little under 10 weeks, we will have expanded from 70 to 180. What this reflects is the really terrific demand in the market from both the sales professionals, clinical professionals, and medical science liaisons, MSLs, to help our physicians learn about RECELL and how to be simple, interested they are to come to work for AVITA. This is a graphical representation of what I just described. And you can see how the burns and full thickness markets overlap each other in a Venn diagram. It's one sales force and in fact, nearly 400,000 new procedures and it's tremendous amount of synergy. So this is a very, very big opportunity for our company. This is a little bit granular, but it's very important because this has to do with one of the elements that has caused us to move up our expansion plans. What you see here on the left, when we submitted for full thickness, we actually were submitting with the expectation of getting the approval with the indications on the left side of this slide. What we received was also the approval for what you see on the right side of the slide. So this is nearly a dozen different indications, which have at least 4 to 5 physician specialties within the hospital, at least 10 different DRGs. So what happens is when we go to a hospital to get approval, we learned during the June to October time frame that it took longer to get approval solely because of the complexity of getting 4 or 5 physician specialties and 8 to 10 different indications and their reimbursement all lined up for the Value Analysis Committee, which is principally, it's administrative by the hospital. And principally, what they're focused on is economics, does a new product that comes in make economic sense for their hospital. So that is something we've talked about a little bit in our calls this quarter. It will be the last time you hear from us because we have figured out how to solve this complexity. And as we exited the year, we had well over 100 accounts that are in some stage of the Value Analysis Committee process, and we add to them every day and every day, some fall out. Let me complete that thought. And so what that implies for success for us, and later when David talked about guidance, it means of 200 hospitals for the year, it means approximately 15 or so every month. And what we learned is that by filling the pipeline and expanding our selling time in the hospital, which our expansion we're doing on April 1 will do, we can maintain our growth rate. And that really supports the reduction of our burn over time in our use of cash. So over time, we will continue to expand our gross revenue and gross profit. I'm going to take a minute and talk a little bit about our international commercialization strategy. You may recall in the past, I described a filter. It had 3 really relevant elements. One, the country would have to have the health care system that could utilize RECELL. If they don't have a health care system that can use it, it's not really going to be successful. The second, they had to have the economic ability to pay for it. It's an advanced technology. They don't pay for it in certain countries as they cannot afford it. And third, the population that would support an entry to market strategy. When you apply that filter, the world looks like to us from international go to Australia, go to most of the European Union, and go to Japan. Now we're in Japan already with the burn indication, but we would be looking to expand it. One of the benefits is with this third-party strategy, there's 2 really central benefits. One is fundamental local knowledge. Getting a good distribution partner is they know the hospital, they know the system, they know the key opinion leaders, they understand reimbursement and they know how to do business in that country, big advantage. The second of going with this strategy is our revenue produces contribution margin that is positive. We're not investing very much to build this. And what we expect is that by the end of this year, we will have established our distribution footprint in these 3 regions of the world. In November, we entered into an agreement with PolyMedics Innovations. And they have the territory of Germany, Austria, and Switzerland. So we expect those sales to start occurring here in Q1. They launched on time in January. And during the next 6 months to 12 months, you'll see us come on board. In Australia, we're right now working to identify an appropriate partner. We're -- and within the EU, we're looking at the additional countries. It's not EU because it's the U.K., they left the EU, but U.K. is included. U.K. and France and Italy and Spain, Belgium Holland combo, Benelux, and of course, the 4 Nordic countries. Those will be what we expect by the year-end. So we expect to enter '25 with a good solid base to grow our business in these markets. Let me turn a little bit to product portfolio expansion. We signed an agreement, and it's a highly durable enduring -- highly durable agreement, meaning it's very long term, and we have a lot of ability to maintain it on our own in an affirmative way. So the product is to commercialize a dressing called PermeaDerm, which is a biosynthetic wound matrix. So PermeaDerm is a clear. So when you get these severe wounds, when you lift up the dressing to see how the wound is doing, you disturb the healing. With PermeaDerm, you can see through it. It's also porous. So the porosity allows for air to come in and for lack of a better expression, and excuse me for it, it allows to ooze, the excess fluid from the wound to seep out and be cleaned up by the caregiver. Very important. The third important element is that porosity is variable, meaning you can stretch the dressing and make the porosity greater or even apply it in its out-of-the-box level. So it is really effective and very -- a lot of advantages from the wound dressing world. Now what should you expect from that? How should you think about that? If we used it on RECELL, so it's used with RECELL, but it's also used in partial thickness burns, which don't get a RECELL. So it expands our reach of market opportunity. It also would be used in all of those full thickness cases. If you're trying to understand what the revenue and margin opportunity for it is, think of it as being used with RECELL, 1,920, which is, let's just say, 2,000 square centimeter. So that's 10% total body surface area. And you would make approximately a sale of $2,100 to $2,200, which we share 50-50 in the average selling price. So that would mean on that RECELL sale, we add a sale of $2,000, and we capture additional gross profit of $1,000. So this is very leverageable, very good for our customer, very good for the patient. And so when we look at our product portfolio for RECELL, we're looking at other areas as well. We want to enter the area called dermal scaffolds, which are used differently than a dressing. They are used to granulate cell growth. We're very actively working to develop a co-development partner. In fact, just yesterday, we did animals with 2 additional candidates. And we intend during this year to identify one. And this is a very important market because it's part of the treatment of acute wounds, which is really the core business of AVITA. Now let's look long term and let's look at next to the core business, but what's also out there. We've received approval for treating the autoimmune condition of vitiligo. Now, vitiligo is neither contagious nor death -- it doesn't cause death. But it does cause meaningful impact to the patient in terms of the disfigurement and at least in their eyes, where they don't have pigment. When we got the FDA approval, we have to subsequently go for reimbursement. And it's very different than most other products because CMS, Center for Medicare and Services, their beneficiaries are all 65 and older. Commercial insurance treats the patients that are 40, right? So very different. And those companies are trying to do it for a profit. So what we're doing is building the case for coverage with vitiligo. So we, in July, started enrolling the TONE study, which was to have 100 patients. We actually enrolled 109. And that 109 patients are being followed for 6 months and 12 months. And we are measuring within it repigmentation and we're measuring 4 different quality of life measures to try and look at their utilization of mental health services. It turns out that the vitiligo patient population consumes higher health care resources than just the regular population. And predominantly, that's a consequence of metal health and depression and those types of issues for them. So one, that is a one leg in the stool of getting reimbursement. The second leg of the stool is health care economics. So we are working with a third-party health economics firm to create a publication that evaluates the longitudinal cost of treating a vitiligo patient. And subsequently, the reduction you can expect from improved quality of life. Both of those -- so key milestones. Both of those studies should publish around the first quarter of '25, and it's difficult to know when the journals will publish. And sometime within second or third quarter of '25, we will begin discussions with the commercial payers, which in the United States are all regional. They're state-regulated. So we'll be going state by state. So a success model will be that we get approval in the state, we go to market, hire a team for that state. It won't be a large sudden expansion. It will be a rolling expansion. And if you remember when I said we were going profitable in Q3, this will be something we fund with our excess cash that we're producing. So vitiligo is a -- from a revenue point of view, it's a '26 or beyond opportunity, a very large one, but one that requires great care and approach to the market. Now we're going to talk about the financials, and I'm going to let -- pass over to David, to have him take you through these.

Thanks, Jim. And for everyone's information, this is my first trip to Australia with Jim. We're here together, visiting shareholders and potential investors. It just shows our commitment to the Australian market, and I look forward to continuing to come here over the next quarters. We ended 2023 with -- very strong, and we're starting the year in a very strong financial position. We ended the year with almost $90 million of cash. We had $14.1 million of revenue in the fourth quarter, a 50% increase over the same period in 2022, a little less than $50 million for the entire year, which is a 46% increase over the same period in 2022. Our gross margin was right in where we thought it was going to be. We had given guidance of 83% to 85%. So at the upper end. So almost 85%, 84.5% for gross margin percentage. Looking forward to 2024, our guidance for the first quarter is $14.8 million, $15.6 million for the quarter, in the range of 40% to 50% over the same period in 2023. For the full-year, we're looking at $78.5 million to $84.5 million with a midpoint of around 63% growth for the year for the same period in 2023. One point to make very clearly here is that the PermeaDerm opportunity, the product expansion that Jim talked about, that revenue, which we haven't given guidance on yet, but we will as we get more experience over the next quarter or so is not included in our guidance for full-year 2024. That is all going to be upside. When we start selling that, we are planning to launch that mid-March. As Jim has mentioned a number of times, and it's very important, we see a path forward to cash flow breakeven and GAAP profitability no later than the third quarter of 2025. And for a company that has been historically burning cash and having significant losses, to see a path to profitability and to start generating cash is a huge milestone for this company. We did, and I'll just mention it real quickly, I think it is important to point out. As everyone knows, we did enter into a debt facility with OrbiMed last year in October. Our total debt facility was $90 million. We took down $40 million at close. And we did that so that we would have enough cash on our balance sheet to meet our goals and to reach the profitability that I just talked about in 2025. There are additional tranches that are available under the OrbiMed debt. But at this time, we don't see a need for either one of them. They're 2 $25 million tranches. And if we don't take it down by December 31, the first one, they both expire. And so we will only end up taking $40 million of debt. We don't see a need also, as I said, for the 2 $25 million tranches and the $40 million that's sitting on our balance sheet right now, we don't necessarily see a need to tap into that either. That is sitting in U.S. treasuries and is earning the company interest at a rate of greater than 5%. So it really is offsetting the cost of capital of borrowing that money from OrbiMed. Next slide. So we've talked a number of times about this, but I think the main point on this slide is just the consistent growth that we are seeing in this company. For the last 4 quarters, we've had 40%, 42%, 51%, and in the last quarter, 50%. And we've talked about it, Jim has talked about it many times that over the next 3 years to 5 years, we do see that growth rate continuing at 50% or greater as we grow our revenue through the new indications for full-thickness skin defects, expanding our product portfolio and also increasing our already core business of burns. So Jim, I think I'll turn it over to you now for a summary.

Really '23 was a year of inflection for the company. What we did is and we continue to do is increase our share in the burn centers, which is our original indication. We've expanded our sales force. And by doing so, we can go for the 30% of the burn market that we weren't reaching. The full-thickness opportunity resulted in a 10x expansion of our business opportunity. RECELL GO, which incidentally is there's a corresponding product portfolio ad we haven't talked about with RECELL GO. And the standard size RECELL GO is going to launch in June, and there is a RECELL GO mini behind it. One of the things we found in full thickness is that a good many of the graft opportunities were 500 square centimeters or less, and we will be launching the RECELL GO mini by year-end. So we'll be submitting immediately after RECELL GO approval as a product line extension, and we expect approval by year-end. During '23, we began -- we defined and began our international expansion. By the end of '25, we plan to have our footprint in place. Vitiligo is making progress on its potential and its future with the TONE study. More to come on vitiligo, but in the meantime, by adding PermeaDerm, by investing our time in scaffolds, RECELL GO mini, RECELL GO standard, we are really focused on the enormous opportunity in full thickness and in burns and which is what we refer to as our core wound business. So with that, I think we'll take some questions, right?

Thank you, Jim. We'll now move on to the Q&A. [Operator Instructions] I'll now hand over to Jessica Ekeberg to run the Q&A.

Thank you, Rudi. The first question is for Jim. By the end of 2024, should we expect RECELL to be available in 140 burn centers and 200 trauma centers for a total of 340 out of the targeted 800 accounts? And are you able to provide any strategic commentary around the targeted new trauma account? For example, are you targeting or expecting approval on high-volume accounts first?

I think on a macro level, the range of those numbers, 140 plus 200 new accounts is, in general, correct, whether it's 197 or 200. In that range, we are expecting to be in 340, 350 accounts by year-end. We did triage the trauma centers by their size and the amount of graft team that they performed and the patient population they saw. So we did go to so to speak the biggest first. So by year-end, we will have achieved a meaningful penetration into the full thickness and of course, we're already very deep into the burns market. But we'll still have an opportunity ahead of us in the next couple of years, which is why David emphasized, our core wound business is a 50% growth vehicle for the next 4 years to 5 years. So we have -- there's more than getting an account just for one little piece of color. You get an account, that means you get into the VAC committee, but then you have to work with the different specialties to get full applications just like we do in burns. We don't get approval on a burns account. And suddenly, every burns patient gets RECELL. We have about 20% to 25% share of the burn market, and it grows 30%, 40% plus still. And in time, we expect to be dominant in the standard of care over 50%, but it takes time and it takes work by our sales team. Same is true for full thickness. So getting in those accounts is the beginning and not the destination.

Thank you, Jim. Any feedback from new surgeons on their intent to use?

The feedback we're receiving is quite interesting because it has surprised us a bit in the following way, is there turns out to be many who are willing to utilize RECELL in its broader indication. And the pro of that is it's validating the broader application of RECELL. The hesitancy we have, of course. In some of those cases, we haven't conducted any research on those indications specifically, although they are graft procedures. So you could say a graft is a graft, but we don't see the world quite that way. And their willingness to try it on new things is very encouraging because that means they're willing to try RECELL. So that's been one learning. A second learning is a good percentage of them are 500 square centimeters or less. And that caused us to initiate the RECELL GO mini project, which is currently in final design form, and we're preparing to start the testing for it. That should be completed by June. So when we get RECELL GO standard size approved, we'll submit the mini, which will use the same durable, just a different sized set. So that would be some things we've learned.

Great. What percentage of last year's new sales representatives have reached breakeven?

Well, actually, well over 90%. We had less than a handful who didn't. And of course, those tend not to be -- they tend to be positions that turnover. So we did have a few but not -- far less than 10%.

Great. We have a few questions for David now. David, can we expect any additional non-cash items during 2024?

Thanks, Jessica. The simple answer is no. There will be no significant non-cash items like we had to present in the fourth quarter. And just a comment on that. That was, again, a non-cash item of $9.4 million, which was cumulative translation adjustments from foreign exchange. It was non-cash. And it's resulting from simplifying our corporate structure, our international corporate structure. That in no way is a non -- is indicating that there's not a commitment to Australia or to Europe. It's just a reorganization of entities that we don't use any longer. And we don't see any non-cash items like that in 2024.

Great. In terms of the cash burn rate over the course of the year and towards profitability in 2025, how should we think about it?

Yes. So a couple of thoughts on that. And we need to kind of bifurcate cash burn versus use of cash. In the first quarter of this year, use of cash, that is what we're using our cash for will go up because we are buying inventory for PermeaDerm. We are also building inventory for RECELL GO, both the durable and the disposable. But both of those items, even though we're using that cash in the first quarter, that turns into cash when we sell it and it generates revenue for us. So I just want to make sure that we're talking about cash burn and cash burn means how much cash we're burning from an operating standpoint. That is the revenue less our operating expenses. And as you would expect, given that we are guiding to profitability and GAAP profitability -- or GAAP profitability and cash flow breakeven by the third quarter of 2025, our cash burn, that is revenue less operating expenses is going to continue to decrease to a point where in 2025, we're going to cross over. So over the next 6 quarters, you will see our cash burn decrease considerably.

Thank you. In the next 4 quarters or so, should there be a recession? Has the company made contingency plans on how the company finances will be handled, specifically cash, and how you move forward with your business in such an environment?

Yes. I think every company has to plan for these sort of possibilities such as a recession. Unfortunately -- fortunately for us, unfortunately, for our patients, these surgeries that are done and using RECELL are not elective surgeries. These are surgeries that are very significant burns and significant full-thickness skin defects. And so from our standpoint, a recession shouldn't impact our business significantly. However, if we do see that, that there is some impact to a recession over the next 18 months, there are significant levers that we can pull in order to preserve cash. And as a public company, we have those plans in place.

Great. Now we're going to turn to RECELL GO and it looks like RECELL has many questions. Since RECELL mini is expected to receive FDA approval by year-end, does it have Breakthrough Device Designation?

Yes. Actually, simple answer is yes. It's a derivative of the RECELL Breakthrough Device Designation, where RECELL GO became a derivative beneficiary of that designation, and RECELL GO mini also received that derivative-related Breakthrough Device Designation. So that means a real-time review absent a material information request. And the request, of course, that we would expect, we just learned about. And so we're doing that testing in advance of submission over the next couple of few months before the June submission.

Great. In terms of RECELL GO, are you able to provide an inventory production schedule?

No, but I can give you some insight to it qualitatively. First of all, we are submitting the information request for RECELL GO on Wednesday this week -- Wednesday or Thursday this week. And that gives us a May 30 approval. Now to do that and include our Ventura facility as a manufacturing site, we would -- we have had to already qualify the assembly of the durable, the RECELL GO durable, which we will be giving away but owning that performs the work for the disaggregation. And for the disposable cassette of RECELL GO. So both of them have been qualified in manufacturing, and we have completed some short production runs. We will go into production during -- by April 1, ahead of the May 30 launch. So we feel very comfortable in our readiness for that launch vis-a-vis inventory.

Great. Are you able to say what the capacity of the manufacturing facility will be after the 10x expansion?

Yes. So to be clear, what the objective was. So Ventura, when we think about the assembly of RECELL, there are 5 different biologic tests that are regulated that occur during the production process. So to move it, it's the very complex regulatory activity and it is time-consuming. Now what -- 2 things changed at the end of last year. One, we established that cold chain shipping, which control the temperature of the enzyme. It was no longer needed. We demonstrated stability across a broad temperature range. That packaging is huge. It took up a big part of the warehouse. The second element is that we were managing vendor inventory for BARDA. So vendor owned -- the vendor-managed inventory for BARDA. So the volume that, that was, was 1 year of production. That agreement ended here on December 31, and we no longer have to keep 1 year of production isolated and rotating. So it expanded the space. These 2 items expanded the space in Ventura. So what we did is we set out with a goal to expand the capacity of Ventura by 10x. That was the objective. How would we do to that? What will we have to change? Because what's also coming to Ventura is assembly of RECELL GO durable, RECELL GO disposable, a service center for the RECELL GO durable. So when it's partially -- they're good for 200 cases. But if one would become a return to us, it was broken or such, we have to inspect it and repair it. And then, of course, we're going to expand our physical distribution because we'll be distributing PermeaDerm and other products there. So if you look at last year's production, it was approximately 8,000 units, 7,500, 8,000 units, not counting inventory, that's kind of what we sold. So 10x that is somewhere in the 80,000 case -- I mean kit scale, which, of course, is a tremendously big business, but it means that we are very secure in staying in Ventura and being able to build around it, build the organization around it and build the capability of Ventura broadening its scope. So that will be complete by mid-year as well.

Thank you, Jim. Turning to vitiligo. Can we expect study results to be announced for the TONE study prior to these studies being published?

Probably not. And the reason is we want these -- the credibility of this data will lie in the authors and the journals that publish them. And rather than projecting the results ahead of their review and ahead of their commentary would bias the view of those results. And what, of course, we want is those results to get published with the points of view of the investigators who draft and write those studies. And with the journals who peer reviewed them. That's what is important to the commercial payers. So we'll be looking to get them published, and then we'll do an additional release.

What are your expansion expectations in Europe?

Well, I think I have covered that. We're principally looking at EU as an expansion opportunity. Our priority is for '25. We have Germany, Austria, and Switzerland in the ballgame. We're expecting the U.K., France, Italy, Spain, and Benelux, spend on Belgium and Holland and the 4 Nordic countries also to be covered by the end of the year in terms of our distribution partnership.

Thank you, Jim. We have -- looks like a couple more questions. With the recently expanded FDA label full-thickness skin defects, how open are you to partner with Big Pharma? And has there been any interest from larger medical device companies to acquire AVITA Medical?

Well, if anybody was interested in acquiring, of course, we would disclose it, but -- so the answer is no. We're not looking for any partnerships at this time. We think we are in a good place to build this business, create a really broad-based wound care business. That's really our core business and to get profitable on that business on its own with very high growth.

Great. And the last question, can you provide an update on the EB and cosmetic rejuvenation program in terms of what has been achieved to date, anything learned, and where the program is headed or programs are headed?

Yes. There were historically 2 programs, EB and a potential gene editing cosmetic program that was in Houston. We've actually -- and I've announced this in prior times, neither one of these programs really had merit in terms of becoming products. So we've discontinued all time, money, and effort on those programs. So from an update point of view, we don't see them as part of our future. They were academically interesting. They have no prospects to becoming a product that we can foresee or foresee funding. So we're focusing our effort on the core business, wound care, and that's where you'll see our investment.

Thank you, Jim. That concludes today's Q&A session.

That concludes the webinar. We thank you for your participation.